ANDA 090055

STRIDES PHARMA

FDA Drug Application

Application #090055

Documents

• Other: 2015-07-06

Application Sponsors

ANDA 090055

STRIDES PHARMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

250MG

0

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE MOFETIL

FDA Submissions

	ORIG	1	AP	2010-06-10
REMS; REMS	SUPPL	2	AP	2012-09-25
LABELING; Labeling	SUPPL	3	AP	2012-08-29	STANDARD
LABELING; Labeling	SUPPL	4	AP	2013-09-27	STANDARD
REMS; REMS	SUPPL	5	AP	2015-11-13
LABELING; Labeling	SUPPL	6	AP	2016-08-01	STANDARD
LABELING; Labeling	SUPPL	14	AP	2019-11-22	STANDARD
LABELING; Labeling	SUPPL	16	AP	2020-08-04	STANDARD
REMS; REMS	SUPPL	17	AP	2021-01-15
REMS; REMS	SUPPL	20	AP	2021-04-21
REMS; REMS	SUPPL	21	AP	2021-08-11

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	3	Null	15
SUPPL	4	Null	7
SUPPL	5	Null	7
SUPPL	6	Null	15
SUPPL	14	Null	15
SUPPL	16	Null	15
SUPPL	17	Null	15
SUPPL	20	Null	7
SUPPL	21	Null	7

TE Codes

001

Prescription

AB

CDER Filings

STRIDES PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90055
            [companyName] => STRIDES PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MYCOPHENOLATE MOFETIL","activeIngredients":"MYCOPHENOLATE MOFETIL","strength":"250MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MYCOPHENOLATE MOFETIL","submission":"MYCOPHENOLATE MOFETIL","actionType":"250MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)